Alecnib 150 mg (Generic Alectinib) – Everest Pharmaceuticals

Generic Identity: Alectinib

Manufacturer: Everst Pharmaceutical ltd.

Quantity: 56 Tablets

Originator: Alecensa by Roche’s Chugai

  • Medically Reviewes by Dr. Daria Kwaśniewska
  • WHO-GMP standards
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Description

DK
Dr. Daria Kwaśniewska ESMO Certified Consultant Medical Oncologist
Reviewed June 2026
⚠ Prescription required. For informational purposes only. Meds For Cancer is a Named Patient Program facilitator — not a retail pharmacy. A valid oncologist prescription is mandatory before any order is processed.

Is Alecnib 150 mg right for your situation?

Review these criteria with your oncologist before enquiring
✔ You may be a candidate if
  • Confirmed ALK-positive NSCLC on molecular or genomic testing
  • Seeking first-line or post-crizotinib ALK inhibitor therapy
  • Need an affordable WHO-GMP generic alternative to Alecensa® (Roche)
  • Hold a valid oncologist prescription
✖ May NOT be suitable if
  • Lung cancer is ALK-negative (biomarker testing is mandatory before starting)
  • Severe pre-existing liver disease or significant bradycardia
  • Pregnant, planning pregnancy, or breastfeeding
  • Severe renal impairment without oncologist assessment

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What is Alecnib 150 mg?

Alecnib 150 mg is a generic formulation of Alectinib — a second-generation Anaplastic Lymphoma Kinase (ALK) inhibitor — manufactured by Everest Pharmaceuticals Ltd. under WHO-GMP certified conditions in Bangladesh. Each capsule contains 150 mg of alectinib, the same active molecule found in Alecensa® (Roche/Chugai), and is dispensed under the Named Patient Program as a quality-assured, affordable alternative.

Unlike first-generation ALK inhibitors, alectinib is highly CNS-penetrant — a critical advantage, as ALK-positive NSCLC frequently metastasises to the brain.

Generic nameAlectinib
Reference brandAlecensa® (Roche / Chugai)
ManufacturerEverest Pharmaceuticals Ltd.
StandardWHO-GMP Certified
Drug classALK Inhibitor (2nd generation)
Dosage formHard capsule — 150 mg
Pack size56 capsules per pack
RouteOral · twice daily with food
PrescriptionRequired — oncologist only

How Alectinib Works

In ALK-positive NSCLC, a chromosomal rearrangement fuses the ALK gene (most commonly with EML4) to create a constitutively active fusion protein that drives uncontrolled tumour cell growth. Alectinib selectively and potently inhibits ALK and its resistance mutants, blocking this survival signal at the source.

Alectinib’s key clinical advantage is its ability to cross the blood-brain barrier effectively. In the landmark ALEX trial, alectinib reduced the risk of CNS progression by 84% versus crizotinib in the frontline setting. NCCN guidelines designate alectinib as a Category 1 preferred agent for first-line treatment of ALK-positive metastatic NSCLC. View NCCN NSCLC Guidelines →

What to Expect: First 30 Days

Alectinib is generally better tolerated than first-generation ALK inhibitors. Most patients experience milder side effects with a manageable early pattern.

  • Week 1–2: Mild fatigue, constipation, or muscle aches are the most common early complaints. Photosensitivity can develop early — use broad-spectrum sunscreen and protective clothing outdoors from day one.
  • Weeks 2–3: Your oncologist will arrange liver function and CPK blood tests. A mild bradycardia may be detected on ECG — usually asymptomatic but requires monitoring.
  • Week 4: Many patients report stable or improving energy. Imaging typically shows early tumour response, including CNS lesion stabilisation, by the end of the first treatment cycle.

Side Effects

Alectinib is generally well-tolerated compared to chemotherapy and first-generation ALK inhibitors. Most side effects are manageable with dose adjustment or supportive care.

Common · Usually Manageable

  • Fatigue and weakness
  • Constipation
  • Muscle pain (myalgia) and joint pain
  • Photosensitivity — avoid direct sun
  • Peripheral oedema (swollen ankles)
  • Mild nausea or stomach discomfort
  • Rash or dry skin

Serious · Report Immediately

  • Hepatotoxicity (elevated liver enzymes)
  • Interstitial lung disease / pneumonitis
  • Symptomatic bradycardia
  • Severe muscle damage (CPK elevation)
  • Haemolytic anaemia
⚠ Contact your oncologist immediately if you experience:
  • New or worsening breathlessness, dry cough, or fever (possible pneumonitis)
  • Yellowing of skin or eyes, dark urine, or right-sided abdominal pain (hepatotoxicity)
  • Feeling faint, dizziness, or very slow heartbeat (symptomatic bradycardia)

How to Take Alecnib 150 mg

Standard dose: 4 capsules (600 mg) twice daily with food. Take approximately 12 hours apart for consistent drug levels.

  • 1
    Twice daily with food — take approximately 12 hours apart (e.g. with breakfast and dinner).
  • 2
    Swallow capsules whole with a full glass of water. Do not open, crush, or dissolve them.
  • 3
    Sun protection is essential — apply broad-spectrum SPF 50+ sunscreen and wear protective clothing whenever outdoors.
  • 4
    Never stop without your oncologist’s instruction — abrupt discontinuation risks rapid disease progression.
  • 5
    Storage: below 30°C, protected from light and moisture, out of reach of children.

Caregiver Guidance

  • Monitor heart rate daily — alectinib can cause bradycardia. If the patient reports dizziness, lightheadedness, or fainting, contact the oncologist immediately.
  • Sun protection every day — ensure sunscreen is applied before any outdoor activity, even on cloudy days.
  • Watch for breathing changes — new breathlessness, persistent dry cough, or fever can signal pneumonitis. Report any respiratory change immediately.

If the Medicine Stops Working

Alectinib resistance typically develops through on-target ALK mutations (most commonly G1202R) or off-target bypass mechanisms involving alternative kinase activation. When progression occurs, your oncologist will arrange a repeat biopsy or liquid biopsy to characterise the resistance mechanism. Lorlatinib (a third-generation ALK/ROS1 inhibitor) retains activity against most alectinib-resistant ALK mutations and represents the standard next-line option for many patients.

Frequently Asked Questions

Do I need a biomarker test before starting Alecnib?
Yes — this is non-negotiable. Alectinib only works in ALK-positive NSCLC. Before prescribing, your oncologist must confirm ALK rearrangement through an FDA/CE-approved test such as FISH, IHC, or NGS of your tumour sample. Starting without confirmed ALK positivity is clinically inappropriate.
Can Alecnib treat brain metastases?
Yes — this is one of alectinib’s most significant clinical advantages. In the ALEX trial, alectinib reduced the risk of CNS progression by 84% versus crizotinib. Many patients with brain metastases are able to defer or avoid whole-brain radiation when on alectinib.
How is Alecnib different from Alecensa®?
Both contain alectinib 150 mg as the active ingredient. Alecensa® is the originator brand from Roche/Chugai; Alecnib is the WHO-GMP certified generic by Everest Pharmaceuticals Ltd. The active molecule and dosing are identical. The principal difference is cost — generic alectinib is substantially more accessible for patients where Alecensa® is unaffordable or unavailable.
Why must I take Alecnib with food?
Taking alectinib with a high-fat meal increases drug exposure by approximately 3-fold compared to fasted state. Your oncologist has set your dose based on the assumption you will take it with food — taking it on an empty stomach may result in sub-therapeutic drug levels.
How long will I be on Alecnib?
Alecnib is taken continuously until disease progression or unacceptable toxicity. In the ALEX trial, median progression-free survival exceeded 34 months — significantly longer than first-generation inhibitors. Some patients remain on alectinib for several years. Your oncologist will reassess regularly.
What if I miss a dose?
If you miss a dose and it is more than 6 hours until your next scheduled dose, take the missed dose as soon as you remember. If it is less than 6 hours, skip it and continue normally. Do not double-dose. If vomiting occurs right after a dose, do not re-dose — continue with the next scheduled dose.
🛡 Named Patient Program — Regulatory Framework

Meds For Cancer operates as a Named Patient Program (NPP) facilitator. Under this framework, WHO-GMP certified medicines are made available to individual patients with a confirmed medical need and a valid oncologist prescription, in countries where the branded product is unavailable or unaffordable.

This service does not constitute retail pharmacy dispensing. A prescription review is mandatory before any order is processed.

Clinical References
  • Peters S, et al. Alectinib versus crizotinib in untreated ALK-positive NSCLC (ALEX). NEJM 2017;377:829–838.
  • Nokihara H, et al. Alectinib versus crizotinib in ALK-inhibitor-naïve ALK-positive NSCLC (J-ALEX). Lancet Oncol 2017;18:765–775.
  • NCCN Clinical Practice Guidelines in Oncology: NSCLC. V5.2026.
  • Gainor JF, et al. Molecular mechanisms of resistance to first- and second-generation ALK inhibitors. Cancer Discov 2016;6:1118–1133.